Candel Therapeutics

QC Documentation Specialist

Needham, MA
Full Time
Mid Level

  • Location: Hybrid, Needham, MA 

  • Salary:  $88k-$100k  

Why Work With Us?   
At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.   

Our Science: Advancing Cancer Immunotherapies   
Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com   

Position Summary: 

Cross-functional to support relevant Quality Systems GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH Q10, ISO). Also supports the implementation and improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness. 

Essential Areas of Responsibility: 

  • Administers Document Management Program and provides support to end users for the creation, revision, and retirement of documents including: 

  • Reviews GxP documents and records for completeness and compliance with internal procedures and applicable regulations and ensures ALCOA++ principles are followed to ensure data robustness. 

  • Supports and manages document lifecycle in the Electronic Quality Management System (eQMS) 

  • Maintains and improves Document Management Program procedures 

  • Provides training on the Document Management Program 

  • Acts as Administrator for Document Management within the eQMS 

  • Manages physical document archival and retention program 

  • Administers the Training Management Program and provides support to end users for the maintenance of training activities including: 

  • Maintains user roles, training curricula, and training assignments. 

  • Maintains and improves Training Management Program procedures 

  • Provides training on the Training Management Program, as well as Employee Onboarding Program related policies and procedures. 

  • Assists document owners in generating training materials and quiz questions 

  • Acts as Administrator for Training Management within the eQMS 

  • Additional duties to include: 

  • Inspection readiness and execution tasks, as assigned 

  • Internal audit support 

  • Deviation, CAPA, Change Control, and Supplier Qualification support 

  • Preparation of Quality Management System metrics 

  • eQMS, design and validation support 

  • Continuous Improvement initiatives 

  • Other responsibilities as assigned by management

Education, Experience and Skill Requirements:   

Education:  

  • BS/BA in a scientific or engineering discipline with 6+ years of experience in pharmaceutical/ biotech industry within Quality Assurance or Quality (Assurance) exposure, or equivalent experiences 

  • Or, Associate’s degree in a scientific or engineering discipline with 8+ years of Quality experience or Quality (Assurance) exposure or equivalent experiences 

Experience:    

  • Knowledge in 21 CFR Part 11, Annex 11, CFR 210, CFR 211, GxP practices 

  • Knowledge of current regulatory and industry guidelines 

  • Exposure to global health agency regulations 

  • Internal audit/self-inspection experience 

  • Experience in electronic Quality Management Systems 

  • Proficient in Microsoft Office suite (Word, Excel, PowerPoint, Outlook, and Teams) 

  • Familiar with SmartSheet and SharePoint platforms 

  • Excellent written and oral communication skills 

  • Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail in a rapidly changing environment 

  • Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner 

  • Highly motivated, ethical individual with excellent time management skills 

  • Skilled at building consensus, securing stakeholder buy-in, and advancing strategic priorities in a matrixed organization 

Must be authorized to work in US. We cannot provide sponsorships. 
 
*** NOTE: We are not accepting resumes from agencies. *** 

Share

Apply for this position

Required*
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 05/31/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*